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采用单倍体或串联自体干细胞移植对首次复发/难治性霍奇金淋巴瘤进行风险适应性挽救治疗:GELA/SFGM研究组前瞻性多中心H96试验结果

Risk-adapted salvage treatment with single or tandem autologous stem-cell transplantation for first relapse/refractory Hodgkin's lymphoma: results of the prospective multicenter H96 trial by the GELA/SFGM study group.

作者信息

Morschhauser Franck, Brice Pauline, Fermé Christophe, Diviné Marine, Salles Gilles, Bouabdallah Reda, Sebban Catherine, Voillat Laurent, Casasnovas Olivier, Stamatoullas Aspasia, Bouabdallah Krimo, André Marc, Jais Jean-Philippe, Cazals-Hatem Dominique, Gisselbrecht Christian

机构信息

Service des Maladies du Sang, Hôpital Huriez, Centre Hospitalier Universitaire Lille, rue Michel Polonovski, 59037 Lille Cedex, France.

出版信息

J Clin Oncol. 2008 Dec 20;26(36):5980-7. doi: 10.1200/JCO.2007.15.5887. Epub 2008 Nov 17.

DOI:10.1200/JCO.2007.15.5887
PMID:19018090
Abstract

PURPOSE

A prospective multicenter trial evaluated a risk-adapted salvage treatment with single or tandem autologous stem-cell transplantation (ASCT) for 245 Hodgkin's lymphoma (HL) patients who experience treatment failure with first-line therapy.

PATIENTS AND METHODS

Poor-risk patients (150 with primary refractory disease or > or = two of the following risk factors at first relapse: time to relapse < 12 months, stage III or IV at relapse, and relapse within previously irradiated sites) or intermediate-risk patients (95 with one risk factor at relapse) were eligible for tandem or single ASCT, respectively.

RESULTS

Among poor-risk patients, 105 (70%), including 30 of 55 with cytoreductive chemotherapy-resistant disease, received tandem ASCT, whereas 92 intermediate-risk patients (97%) received single ASCT. According to intent-to-treat analysis, the 5-year freedom from second failure and overall survival (OS) estimates were 73% and 85%, respectively, for the intermediate-risk group and 46% and 57%, respectively, for the poor-risk group. Outcomes were similar for primary refractory and poor-risk/relapsed HL. For patients with chemotherapy-resistant disease, the 46% 5-year OS rate achieved with tandem ASCT compares favorably with the previously reported 30%. Outcomes for partial and complete responders to cytoreduction receiving tandem ASCT did not differ significantly and were better than those previously reported for partial responders receiving single ASCT, but not superior to those reported for complete responders receiving single ASCT. Six poor-risk patients (4%) died from toxicity.

CONCLUSION

Single ASCT is appropriate for intermediate-risk patients. For poor-risk patients, our results suggest a benefit of tandem ASCT for half of the patients with chemotherapy-resistant disease and partial responders, but not for complete responders to cytoreductive chemotherapy.

摘要

目的

一项前瞻性多中心试验评估了针对245例一线治疗失败的霍奇金淋巴瘤(HL)患者采用单倍体或串联自体干细胞移植(ASCT)进行风险适应性挽救治疗的效果。

患者与方法

高危患者(150例原发性难治性疾病患者或首次复发时具有以下至少两项危险因素:复发时间<12个月、复发时为III期或IV期、在先前照射部位复发)或中危患者(95例复发时具有一项危险因素)分别符合串联或单倍体ASCT的条件。

结果

在高危患者中,105例(70%),包括55例对减瘤化疗耐药疾病患者中的30例,接受了串联ASCT,而92例中危患者(97%)接受了单倍体ASCT。根据意向性分析,中危组5年无二次失败生存率和总生存率(OS)估计分别为73%和85%,高危组分别为46%和57%。原发性难治性和高危/复发性HL的结果相似。对于化疗耐药疾病患者,串联ASCT实现的46%的5年OS率优于先前报道的30%。接受串联ASCT的减瘤部分缓解和完全缓解患者的结果无显著差异,且优于先前报道的接受单倍体ASCT的部分缓解患者,但不优于接受单倍体ASCT的完全缓解患者。6例高危患者(4%)死于毒性反应。

结论

单倍体ASCT适用于中危患者。对于高危患者,我们的结果表明,串联ASCT对一半化疗耐药疾病患者和部分缓解患者有益,但对减瘤化疗完全缓解患者无益。

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